2023
Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer
Bauman J, Saba N, Roe D, Bauman J, Kaczmar J, Bhatia A, Muzaffar J, Julian R, Wang S, Bearelly S, Baker A, Steuer C, Giri A, Burtness B, Centuori S, Caulin C, Klein R, Saboda K, Obara S, Chung C. Randomized Phase II Trial of Ficlatuzumab With or Without Cetuximab in Pan-Refractory, Recurrent/Metastatic Head and Neck Cancer. Journal Of Clinical Oncology 2023, 41: 3851-3862. PMID: 36977289, DOI: 10.1200/jco.22.01994.Peer-Reviewed Original ResearchConceptsMedian progression-free survivalProgression-free survivalObjective response rateRecurrent/metastatic headCMET overexpressionMetastatic headCombination armAntiepidermal growth factor receptor monoclonal antibodyNoncomparative phase II studyRecurrent/metastatic HNSCCRandomized phase II trialEnd pointNeck squamous cell carcinomaHPV negative subgroupPhase II studyPrimary end pointSecondary end pointsHPV-positive diseaseHuman papillomavirus (HPV) statusMajor prognostic factorPhase II trialKey eligibility criteriaSquamous cell carcinomaReceptor monoclonal antibodyHPV-negative HNSCC
2021
Devising novel imaging biomarkers for Human Papillomavirus (HPV) status in oropharyngeal squamous cell carcinoma (OPSCC): applying radiomics and machine learning algorithms
Haider S, Mahajan A, Zeevi T, Forghani R, Kann B, Judson B, Burtness B, Sharaf K, Reichel C, Baumeister P, Payabvash S. Devising novel imaging biomarkers for Human Papillomavirus (HPV) status in oropharyngeal squamous cell carcinoma (OPSCC): applying radiomics and machine learning algorithms. Laryngo-Rhino-Otologie 2021, 100: s99. DOI: 10.1055/s-0041-1727889.Peer-Reviewed Original Research
2020
Potential Added Value of PET/CT Radiomics for Survival Prognostication beyond AJCC 8th Edition Staging in Oropharyngeal Squamous Cell Carcinoma
Haider SP, Zeevi T, Baumeister P, Reichel C, Sharaf K, Forghani R, Kann BH, Judson BL, Prasad ML, Burtness B, Mahajan A, Payabvash S. Potential Added Value of PET/CT Radiomics for Survival Prognostication beyond AJCC 8th Edition Staging in Oropharyngeal Squamous Cell Carcinoma. Cancers 2020, 12: 1778. PMID: 32635216, PMCID: PMC7407414, DOI: 10.3390/cancers12071778.Peer-Reviewed Original ResearchOropharyngeal squamous cell carcinomaProgression-free survivalPositron emission tomographySquamous cell carcinomaOverall survivalC-indexRisk stratificationCell carcinomaSurvival prognosticationHPV-negative oropharyngeal squamous cell carcinomaPre-treatment PET/CTMetastatic cervical lymph nodesBaseline positron emission tomographyBaseline distant metastasesCervical lymph nodesHuman papillomavirus (HPV) statusAmerican Joint CommitteeKaplan-Meier analysisPET/CT RadiomicsHarrell's C-indexAverage C-indexPET/CTRadiomics imaging featuresCurative intentDistant metastasisPhase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Siu L, Burtness B, Cohen E, Harrington K, Licitra L, Rischin D, Zhu Y, Lee C, Pinheiro C, Swaby R, Machiels J, Tahara M. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6589-tps6589. DOI: 10.1200/jco.2020.38.15_suppl.tps6589.Peer-Reviewed Original ResearchBlinded independent central reviewCombined positive scoreFirst-line pembrolizumabM HNSCCDisease progressionRECIST v1.1PD-L1PD-L1 combined positive scoreECOG performance status 0PD-1 inhibitor pembrolizumabRecurrent/metastatic headEnd pointNeck squamous cell carcinomaCycles of pembrolizumabFirst-line monotherapyPerformance status 0Phase 1b/2 trialManageable safety profileObjective response ratePrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 statusPhase 3 studyProgression-free survivalDevising novel imaging biomarkers for Human Papillomavirus (HPV) status in oropharyngeal squamous cell carcinoma (OPSCC): applying radiomics and machine learning algorithms
Haider S, Mahajan A, Zeevi T, Forghani R, Kann B, Judson B, Burtness B, Sharaf K, Reichel C, Baumeister P, Payabvash S. Devising novel imaging biomarkers for Human Papillomavirus (HPV) status in oropharyngeal squamous cell carcinoma (OPSCC): applying radiomics and machine learning algorithms. Laryngo-Rhino-Otologie 2020, 99: s163. DOI: 10.1055/s-0040-1711024.Peer-Reviewed Original Research
2018
HPV status in unknown primary head and neck cancer: Prognosis and treatment outcomes
Cheraghlou S, Torabi SJ, Husain ZA, Otremba MD, Osborn HA, Mehra S, Yarbrough WG, Burtness BA, Judson BL. HPV status in unknown primary head and neck cancer: Prognosis and treatment outcomes. The Laryngoscope 2018, 129: 684-691. PMID: 30151832, DOI: 10.1002/lary.27475.Peer-Reviewed Original ResearchConceptsHPV-negative patientsTreatment deintensificationCN3 diseaseHPV statusNeck cancerUnivariate Kaplan-Meier analysisTumor human papillomavirus (HPV) statusCox survival regressionHPV-negative diseaseIdentifiable primary tumorUnknown primary headHPV-positive patientsHuman papillomavirus (HPV) statusTumor HPV statusKaplan-Meier analysisTreatment-related outcomesSignificant prognostic valuePoor patient survivalCases of headDefinitive chemoradiotherapyDefinitive radiotherapyMetastatic nodesNodal classificationUnknown primaryTherapeutic challenge
2016
Comparison of Upfront Surgery Versus Chemoradiation for cT1-2 N1-2b Oropharynx Squamous Cell Carcinoma Based on Human Papillomavirus Status
Kelly J, Park H, An Y, Decker R, Contessa J, Yarbrough W, Burtness B, Judson B, Husain Z. Comparison of Upfront Surgery Versus Chemoradiation for cT1-2 N1-2b Oropharynx Squamous Cell Carcinoma Based on Human Papillomavirus Status. International Journal Of Radiation Oncology • Biology • Physics 2016, 96: e327. DOI: 10.1016/j.ijrobp.2016.06.1451.Peer-Reviewed Original ResearchAntitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort
Chow LQM, Haddad R, Gupta S, Mahipal A, Mehra R, Tahara M, Berger R, Eder JP, Burtness B, Lee SH, Keam B, Kang H, Muro K, Weiss J, Geva R, Lin CC, Chung HC, Meister A, Dolled-Filhart M, Pathiraja K, Cheng JD, Seiwert TY. Antitumor Activity of Pembrolizumab in Biomarker-Unselected Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results From the Phase Ib KEYNOTE-012 Expansion Cohort. Journal Of Clinical Oncology 2016, 34: 3838-3845. PMID: 27646946, PMCID: PMC6804896, DOI: 10.1200/jco.2016.68.1478.Peer-Reviewed Original ResearchConceptsOverall response rateNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaMetastatic headExpansion cohortPD-L1Cell carcinomaAnti-programmed death-1 antibodySix-month progression-free survivalTreatment-related adverse eventsEnd pointDeath-1 antibodyDose of pembrolizumabAntitumor activityPrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 expressionOverall survival rateDurable antitumor activityFrequent dosing scheduleAssociation of responseAdvanced HNSCCM HNSCC
2014
Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303
Egloff AM, Lee JW, Langer CJ, Quon H, Vaezi A, Grandis JR, Seethala RR, Wang L, Shin DM, Argiris A, Yang D, Mehra R, Ridge JA, Patel UA, Burtness BA, Forastiere AA. Phase II Study of Cetuximab in Combination with Cisplatin and Radiation in Unresectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: Eastern Cooperative Oncology Group Trial E3303. Clinical Cancer Research 2014, 20: 5041-5051. PMID: 25107914, PMCID: PMC4184913, DOI: 10.1158/1078-0432.ccr-14-0051.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingRadiotherapyRisk FactorsSquamous Cell Carcinoma of Head and NeckTreatment OutcomeConceptsProgression-free survivalOverall survivalLA-SCCHNMaintenance cetuximabAdvanced squamous cell headMedian progression-free survivalTwo-year overall survivalNeck squamous cell carcinomaTumor human papillomavirus (HPV) statusGrade 5 toxicityMedian overall survivalMedian radiotherapy doseMost common gradeCycles of cisplatinHuman papillomavirus (HPV) statusPhase II studySquamous cell headTumor HPV statusLonger overall survivalSquamous cell carcinomaOropharyngeal primaryHPV statusII studyPrimary endpointProtocol treatmentp16 status, pathologic and clinical characteristics, biomolecular signature, and long‐term outcomes in head and neck squamous cell carcinomas of unknown primary
Keller LM, Galloway TJ, Holdbrook T, Ruth K, Yang D, Dubyk C, Flieder D, Lango MN, Mehra R, Burtness B, Ridge JA. p16 status, pathologic and clinical characteristics, biomolecular signature, and long‐term outcomes in head and neck squamous cell carcinomas of unknown primary. Head & Neck 2014, 36: 1677-1684. PMID: 24115269, PMCID: PMC3972378, DOI: 10.1002/hed.23514.Peer-Reviewed Original ResearchConceptsSquamous cell CUPNeck squamous cell carcinomaSquamous cell carcinomaUnknown primaryCell carcinomaTissue microarrayOverall survivalP16 statusHuman papillomavirus (HPV) statusMajority of patientsWorse overall survivalLong-term outcomesHPV associationP16 stainClinical characteristicsClinicopathologic characteristicsPrognostic factorsPrognostic featuresPrognostic implicationsExtracapsular extensionP16 stainingYounger ageCarcinomaP16High grade
2013
Association of the 3'-untranslated region KRAS-variant with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.
Weidhaas J, Lee J, Slebos R, Howard J, Perez J, Gilbert J, Nallur S, Paranjape T, Garcia J, Burtness B, Forastiere A, Chung C. Association of the 3'-untranslated region KRAS-variant with cisplatin resistance in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Journal Of Clinical Oncology 2013, 31: 6016-6016. DOI: 10.1200/jco.2013.31.15_suppl.6016.Peer-Reviewed Original ResearchNeck squamous cell carcinomaSquamous cell carcinomaKRAS-variantMetastatic headCell carcinomaP16/HPV statusRecurrent/metastatic headPoor progression-free survivalCisplatin resistanceHuman papillomavirus (HPV) statusProgression-free survivalTG/GGM HNSCCTumor DNA samplesHPV statusPatient demographicsHNSCC patientsClinical outcomesPoor outcomePoor prognosisPrognostic significancePredictive biomarkersClinical trialsProspective validationPromising biomarker